The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for General Utility Surg. Scissors #460180-.
Device ID | K800721 |
510k Number | K800721 |
Device Name: | GENERAL UTILITY SURG. SCISSORS #460180- |
Classification | Scissors, Orthopedic, Surgical |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HRR |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-01 |
Decision Date | 1980-05-08 |